Universal non-custom dental tray having anatomical features to enhance fit

ABSTRACT

A non-custom, tray-shaped dental treatment device includes a moisture-resistant barrier layer having a front side wall and a bottom wall, and a dental treatment composition. In addition, the tray-shaped dental treatment device includes at least one of the following anatomical features to enhance the fit of the device: (1) the bottom wall includes a plurality of cuts positioned to help the bottom wall better conform to abrupt changes in the diameters of a person&#39;s teeth where the bicuspids and canines meet, and/or (2) the bottom wall includes at least one V-shaped or U-shaped indentation configured to be inserted into the depression typically found along the top surfaces of a person&#39;s molars, and/or (3) the front side wall and bottom wall include radii of curvature that account for typical flaring of a patient&#39;s incisors.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.10/783,597, filed Feb. 19, 2004, the disclosure of which is incorporatedherein in its entirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention is in the field of dental tray shaped devices usedto provide a desired dental treatment to a person's teeth. The devicecan be used for dental treatments such as bleaching, administration offluoride, or application of other medicines.

2. The Relevant Technology

Virtually all people desire white or whiter teeth. To achieve this goal,people have veneers placed over their teeth or have their teethchemically bleached. A common bleaching method involves the use of adental tray that is custom-fitted to a person's teeth and that istherefore comfortable to wear. One type of customized tray is made froma stone cast of a person's teeth. Another is customized directly using aperson's teeth as a template (e.g., “boil-and-bite” trays).Non-customized trays that approximate the shapes and sizes of a varietyof users' dental arches have also been used. A dental bleachingcomposition is placed into the tray and the tray placed over theperson's teeth for a desired period of time.

Another bleaching method involves painting a bleaching compositiondirectly onto a person's teeth. A perceived advantage of paint-onbleaching is that it eliminates the need for a dental tray. The maindisadvantage of a paint-on bleaching composition is that it remainsdirectly exposed to the person's saliva and disruptive forces found in aperson's mouth. As a result, a significant portion of the bleachingcomposition does not remain on the teeth where bleaching is desired.Some or all of the composition can dissolve away into the person'ssaliva and/or be transferred to adjacent oral tissues, potentiallyirritating soft oral tissues.

Another tooth bleaching method involves placing a flexible bleachingstrip over a user's tooth surfaces. Conventional bleaching stripscomprise a flexible plastic strip coated with a dental bleaching gel ofmoderate viscosity and relatively low stickiness on the side of thestrip facing the user's teeth. To install the bleaching strip, a portionof the bleaching strip is placed over the front surfaces of the user'steeth, and the remainder is folded around the occlusal edges of theteeth and against a portion of the lingual surfaces. Like paint-onbleaching compositions, this procedure does not require the use ofdental trays. Unlike paint-on bleaching compositions, bleaching stripsinclude a plastic barrier that, at least in theory, keeps the dentalbleaching gel from diffusing into the user's mouth.

In reality, because of the generally poor adhesion of bleaching stripsto the user's teeth, coupled with their generally flimsy nature, it isoften difficult for the user to maintain the bleaching strip in itsproper position for the recommended time. Conventional bleaching stripsare prone to slip off the teeth as a result of even minimal movement ofthe user's mouth, jaw or tongue. Indeed, it is recommended that the usernot eat, drink, smoke or sleep while wearing the bleaching strip. Inpractice, it is difficult to talk or smile while properly maintainingthe bleaching strip in the correct position.

Even if a user successfully maintains a conventional bleaching strip inits proper position during the recommended bleaching period, thebleaching gel often diffuses into the person's saliva, potentiallycausing a poor taste in the user's mouth and possibly discomfort to softoral and throat tissues. The tendency of the bleaching gel to diffuseinto the user's mouth can be accelerated through even minimal shifts ofthe bleaching strip over the user's teeth, with each shift potentiallycausing bleaching gel that remains adhered to the user's teeth, but notcovered by the plastic strip, to be exposed to saliva in the user'smouth. In some cases, the bleaching strip can become so dislodged ormangled that it must be removed by the user and replaced with a freshbleaching strip to complete the recommended bleaching time. Thismultiplies the cost and hassle of using conventional bleaching strips.

In practical terms, the use of conventional bleaching strips can greatlyinhibit even the simplest of activities that involve movement of theuser's mouth or tongue, such as talking, smiling, making other facialexpressions, or even swallowing (which normally occurs subconsciouslythroughout the day). Indeed, the time when a person's mouth and tongueare the least prone to move is at night while the person is sleeping.Unfortunately, it is recommended that conventional bleaching strips notbe used while sleeping, presumably to prevent accidental choking on aninadvertently dislodged bleaching strip. This confirms the tendency ofconventional bleaching strips to easily dislodge from a user's teeth.

Ultimately, the main impediment to successful bleaching is the failureof users to complete the prescribed bleaching regimen. If the bleachingapparatus is difficult to install over a person's teeth, requiresnumerous repetitions to achieve observable results, or is uncomfortableto wear, the user may simply give up and prematurely abort theprescribed bleaching regimen. Thus, even if dental bleaching is possibleusing a particular bleaching apparatus or method, it is less likely tooccur if the inadequacies of the bleaching apparatus or method cause auser to become discouraged before desired results are attained.

In view of the foregoing, there is an ongoing need for improvedbleaching apparatus and methods that are simple and easy to use and thatreliably remain in position over the user's teeth so as to reducediffusion of bleaching composition into a user's oral cavity. Suchimprovements would be expected to improve or encourage compliance by theuser.

BRIEF SUMMARY OF THE PREFFERED EMBODIMENTS

The present invention generally relates to improved dental treatmentdevices used to treat (e.g., bleach) a person's teeth. The inventivetray-shaped device includes a front side wall and a bottom wall. Inaddition, the tray-shaped device includes at least one of the followingfeatures to enhance anatomical fit: (1) the bottom wall includes aplurality of cuts positioned to help the bottom wall better conform toabrupt changes in the diameters of a person's teeth, particularly wherethe bicuspids and canines meet, (2) the bottom wall includes at leastone V-shaped or U-shaped indentation configured to be inserted into thedepression typically found along the top surfaces of a person's molars,and (3) the front and bottom wall include radii of curvature thataccount for typical flaring of a patient's incisors.

In one embodiment of a treatment device according to the invention, thebottom wall includes a cut on either side of the device approximatelycorresponding to the intersection of a person's canines and bicuspids.The cuts help to compensate for the fact that bicuspids aresignificantly thicker than canines by allowing for an abruptdiscontinuity in the bottom wall of the treatment device. Without thesecuts the bottom wall would be harder to conform to the canines since theadjacent bicuspids would tend to push the bottom wall away from thecanines, thus potentially dislodging the bottom wall in this region.These and any other cuts within the bottom wall may also help compensatefor differences between the inner and outer radii of the dental archgenerally defined by the inner and outer tooth surfaces.

In another embodiment of a treatment device according to the invention,the bottom wall may include V-shaped or U-shaped indentations in theregion of a person's molars that cause the bottom wall to better conformto the depression normally found in molars. In the absence of suchV-shaped or U-shaped indentations, the bottom wall of the treatmentdevice may have a tendency to span the molars like a bridge between thegenerally higher outer edges, thereby leaving a gap between the bottomwall and the surface of the molars between the outer edges. Permittingsuch a gap may inhibit or prevent bleaching the depressed molarsurfaces. Moreover, a bottom wall that is stretched between the outersurfaces so as to leave a gap over the molar depressions may result ininadvertent dislodgment of the treatment device when the upper and lowermolars are brought together. For example, if the bottom wall of atreatment device is pushed into the molar depression by the opposingmolars, the front and/or bottom side walls may be pulled down across thetooth surfaces to compensate for this effective lengthening of thebottom wall in the vicinity of the molars.

In another embodiment of a treatment device according to the invention,the front and bottom walls may have different radii in order tocompensate for the general flaring out of a person's incisors toward theincisal edges. Due to such flaring the diameter of a person's dentalarch at the incisal edges is generally greater than the diameter at thegingival margin. Thus the part of the treatment device corresponding tothe incisal edges near a person's incisors may advantageously have alarger radius than the part of the treatment device corresponding to thegingival margin. This helps provide better fit of the treatment deviceover a person's tooth surfaces.

The treatment composition may comprise various forms. According to oneembodiment, the treatment composition comprises a single continuous beador layer adjacent to at least a portion of an inner surface of a barrierlayer. The treatment composition may comprise a sticky viscous gel, aless viscous gel, a highly viscous putty, or a substantially solidcomposition that is less adhesive prior to being moistened with salivaor water but that becomes more sticky and adhesive when moistened.

In another embodiment, the treatment device includes a layer or regionof a substantially solid adhesive composition and a treatment gel orcomposition adjacent to at least one of the barrier layer or adhesivecomposition. The adhesive composition may, in some cases, be formulatedso as to provide the same treatment as the separate treatmentcomposition, a different treatment, or no treatment. It may provide aprotective barrier between the active agent in the treatment compositionor gel and the person's gums. It may include a bleaching agent activatorin the case where the treatment composition includes a bleaching agent.

According to one embodiment, the tray-shaped device includes a barrierlayer made of a moisture resistant material. According to oneembodiment, the barrier layer comprises a thin, flexible membrane formedfrom a moisture-resistant polymer material. It is within the scope ofthe invention to provide barrier layers having any desired thickness orrigidity. In one embodiment, the barrier layer comprises a mixture ofethyl vinyl acetate and polypropylene.

The treatment and/or adhesive compositions may include any desiredactive agent, including, but not limited to, dental bleaching agents,desensitizing agents, remineralizing agents, antimicrobial agents,antiplaque agents, anti-tartar agents, or other medicaments. They alsoinclude at least one tissue adhesion agent. A non-limiting example of asuitable tissue adhesion agent is polyvinyl pyrrolidone (PVP). Thetreatment and/or adhesive compositions may include other components asdesired to yield a final composition having desired properties. Examplesof other components include, but are not limited to, plasticizers andhumectants (e.g., glycerin, sorbitol, and polyethylene glycol), volatilesolvents (e.g., water and alcohols), bleaching agent stabilizers (e.g.,EDTA and alkyl sulfates), bleaching agent activators (e.g., metals andmetal compounds), neutralizing agents, thickening agents (e.g., fumedsilica), flavorants, sweeteners, and the like.

The size and shape of the treatment devices according to the inventioncan be tailored to readily fit a person's upper or lower dental arch.They may also be tailored to fit person's having differently sized orshaped dental arches. The treatment devices are advantageously designedso as to substantially cover the front and lingual surfaces of the teethand/or gums to be treated. The treatment devices are advantageouslyflexible and adhesive so as to readily conform to a wide variety ofdifferently-sized teeth and dental arches.

The treatment devices according to the invention can be designed to beworn for any desired time period. Increasing the concentration of activeagent used generally reduces the required treatment time. Nevertheless,due to the extremely comfortable fit between the inventive treatmentdevices and the person's teeth, it is possible to wear such devices forextended periods of time. Treatment devices according to the inventioncan be designed to be worn while, e.g., talking, sleeping, eating,drinking, smiling, frowning, grimacing, yawning, coughing, smoking, ormaking virtually any facial expression or mouth contortion. This greatlydecreases their intrusiveness into everyday activities compared toconventional bleaching strips, which do not reliably adhere to teeth, orintrusive bleaching devices such as large, bulky bleaching dentalappliances.

The treatment devices can be designed to be worn for as little as a fewminutes or as long as several hours. By way of example, not limitation,a typical treatment session of fast duration may last from about 10 toabout 30 minutes. A treatment session of intermediate duration may lastfrom about 30 minutes to about 2 hours. A treatment session of longduration, including professional or overnight treatment while a personis sleeping, may last from about 2 hours to about 12 hours. Treatmentsessions may be repeated as many times as are needed to obtain a desiredresult. In the case of tooth bleaching, a clinical whitening effect hasbeen observed after only 1-3 whitening sessions. A typical bleachingregimen will preferably include 1-20 bleaching sessions, more preferably2-15 bleaching sessions, and most preferably 3-10 bleaching sessions.

According to one embodiment, the treatment device may include anassociated supporting structure, such as an exoskeleton, prior to use.An exoskeleton may be particularly useful where the barrier layer isvery thin and flexible. The exoskeleton may have the same configurationas the treatment device so as to receive and support the front andbottom walls of the treatment device. The exoskeleton can provideadditional support and ease of placement to the treatment device whilepositioning the device over a person's teeth. In one embodiment, theexoskeleton includes a handle to facilitate gripping and maneuverabilityof the exoskeleton while placing the treatment device over the teeth.Once positioned, the exoskeleton can be removed so as to leave thetreatment device in place over the teeth.

For convenience of use, multiple treatment devices may be packagedtogether and sold as a kit. In one embodiment, the number of treatmentdevices provided with each kit can equal the number of sessions thatrepresent a prescribed treatment regimen. The treatment devices can besealed collectively or individually as desired. They may contain aremovable protective layer on their interior surfaces to protect thetreatment and/or adhesive composition from contamination or moisture. Itis within the scope of the invention to provide a treatment compositionthat is initially separate from a barrier layer in the shape of atreatment device and that is applied onto the barrier layer by the enduser.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by references to specific embodiments thereof, which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1A is a perspective view of an exemplary tray-shaped dentaltreatment device configured to fit over at least a portion of a person'supper dental arch, next to an associated exoskeleton;

FIG. 1B is a perspective view of an exemplary tray-shaped dentaltreatment device configured to fit over at least a portion of a person'slower dental arch, next to an associated exoskeleton;

FIG. 2 is a perspective view of an exemplary tray-shaped dentaltreatment device comprising a barrier layer and a substantially solidadhesive composition placed within an exo-skeleton;

FIG. 3 is a perspective view of the device of FIG. 2 with a geltreatment composition placed within the tray shaped device;

FIG. 4A is a cross sectional view of an exemplary tray-shaped dentaltreatment device with a gel treatment composition placed in the trayshaped device;

FIG. 4B is a cross sectional view of the exemplary tray-shaped dentaltreatment device of FIG. 2;

FIG. 4C is a cross sectional view of the exemplary tray-shaped dentaltreatment device of FIG. 3;

FIG. 4D is a cross sectional view of an exemplary tray-shaped dentaltreatment device with two separate gel treatment compositions placed inthe tray shaped device;

FIG. 5 illustrates an exemplary tray-shaped dental treatment device andassociated exoskeleton contained within a sealed protective packagehaving a peelable cover;

FIG. 6A illustrates a person placing a tray-shaped dental treatmentdevice according to one embodiment of the invention over the upperdental arch;

FIG. 6B illustrates a person having placed a tray-shaped dentaltreatment device according to one embodiment of the invention over thelower dental arch, with a tray-shaped dental treatment device alreadyplaced over the upper dental arch;

FIG. 7A is a close up cross sectional view of the exemplary tray-shapeddental treatment device of FIG. 6B placed over a persons lower dentalarch showing how the V-shaped indentation in the bottom wall isconfigured for insertion into the depression of a person's molars; and

FIG. 7B is a close up cross sectional view of the exemplary tray-shapeddental treatment device of FIG. 6A placed over a person's upper dentalarch showing how the curvature of the front side wall and bottom wallaccount for flaring of a person's incisors.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

I. Introduction and Definitions

The inventive tray-shaped dental treatment device includes amoisture-resistant barrier layer having a front side wall and a bottomwall, and a dental treatment composition. In addition, the tray-shapeddental treatment device includes at least one of the followinganatomical features to enhance the fit of the device: (1) the bottomwall includes a plurality of cuts positioned to help the bottom wallbetter conform to abrupt changes in the diameters of a person's teeth,particularly where the bicuspids and canines meet, (2) the bottom wallincludes at least one V-shaped or U-shaped indentation configured to beinserted into the depression typically found along the top surfaces of aperson's molars, and (3) the front and bottom wall include radii ofcurvature that account for typical flaring of a patient's incisors.

The term “barrier layer”, as used herein, refers to one or more layersof a moisture-resistant material that protect the treatment compositionand/or adhesive composition layer from ambient moisture and saliva foundwithin a person's mouth when the tray-shaped dental treatment device isplaced over the person's teeth. The barrier layer may also serve toprotect the treatment composition and/or adhesive composition frommoisture or other contaminants during storage and prior to use. Thebarrier layer may be in any desired form including, but not limited to,a sheet laminated to a surface of the treatment and/or adhesivecomposition, a coating applied to the treatment and/or adhesivecomposition, or a dental treatment tray.

The term “substantially solid,” as used herein, refers to a compositionthat is in a solid or semi-solid condition. One characteristic of“substantially solid” adhesive compositions according to the inventionis that they become more adhesive when an exposed surface thereof ismoistened with, e.g., saliva or water. When moistened, the surface ofthe adhesive composition turns into a sticky material that is able tomore strongly adhere to teeth compared to a substantially solid adhesivecomposition that has not been moistened. The composition at the surfacemay become a viscous liquid, paste or gel, at least temporarily,depending on the amount of moisture that is applied to the surface ofthe “substantially solid” adhesive composition. Nevertheless, theconsistency of the moistened surface can remain “substantially solid”depending on the degree of initial moistening, or it can stiffen andeven revert back to being “substantially solid” as the initial quantityof surface moisture diffuses into a remaining portion of the“substantially solid” adhesive composition over time (e.g., during ableaching procedure in which the composition is protected from salivaand ambient moisture in a person's mouth by a moisture-resistant barrierlayer).

The term “molecular weight”, as used herein, refers to number averagemolecular weight expressed in Daltons unless otherwise specified.

II. Exemplary Tray-Shaped Dental Treatment Devices

A. Barrier Layer

The tray-shaped dental treatment device includes a barrier layer.According to one embodiment of the invention, the barrier layercomprises a thin, flexible membrane formed from a moisture-resistantpolymer material. In a preferred embodiment, the barrier layer comprisesa thin, flexible layer of a mixture of ethyl vinyl acetate andpolypropylene.

According to another embodiment, it may be formed of a polyolefin orsimilarly moisture-resistant material, such as wax, metal foil,paraffin, ethylene-vinyl acetate copolymer (EVA), ethylene-vinyl alcoholcopolymer (EVAL), polycaprolactone (PCL), polyvinyl chloride (PVC),polyesters, polycarbonates, polyamides, polyurethanes orpolyesteramides. Examples of suitable polyolefins for use in making thebarrier layer include, but are not limited to, polyethylene (PE), highdensity polyethylene (HDPE), low density polyethylene (LDPE), ultra lowdensity polyethylene (ULDPE), polypropylene, and polytetrafluoroethylene(PTFE) (e.g., TEFLON). An example of a suitable polyester for use inmaking the barrier layer includes, but is not limited to, polyethyleneterephthalate (PET), an example of which is MYLAR, sold by DuPont.Plasticizers, flow additives, and fillers known in the art can be usedas desired to modify the properties of any of the foregoing polymersused to form the barrier layer.

B. Dental Treatment Compositions

The dental treatment composition may comprise various forms. Accordingto one embodiment, the treatment composition comprises a singlecontinuous bead or layer adjacent to at least a portion of an innersurface of the barrier layer. The treatment composition may comprise asticky viscous gel, a less viscous gel, a highly viscous putty, or asubstantially solid adhesive composition that is less adhesive prior tobeing moistened with saliva or water but that becomes more sticky andadhesive when moistened.

The treatment composition may comprise various forms. According to oneembodiment, the treatment composition comprises a single continuous beador layer adjacent to at least a portion of an inner surface of a barrierlayer. The treatment composition may comprise a sticky viscous gel, aless viscous gel, a highly viscous putty, or a substantially solidcomposition that is less adhesive prior to being moistened with salivaor water but that becomes more sticky and adhesive when moistened.

In one embodiment, the treatment device includes a layer or region of asubstantially solid adhesive composition and a treatment gel or puttyadjacent to at least one of the barrier layer or adhesive composition.The adhesive composition may, in some cases, be formulated so as toprovide the same treatment as the separate gel or putty treatmentcomposition, a different treatment, or no treatment. It may provide aprotective barrier between the active agent in the gel or putty and theperson's gums. It may include a bleaching agent activator in the casewhere the gel or putty includes a bleaching agent.

Prior to being moistened in preparation for or during use, thesubstantially solid adhesive composition comprises a substantially solidcomposition. The adhesive composition may comprise a single coherentmass or region, or it may comprise a plurality of coherent masses orregions of a substantially solid adhesive composition. Providing asubstantially solid and coherent adhesive composition better maintainsthe tray-like treatment device against the teeth being bleached. This,in turn, promotes better tooth whitening and reduces irritation tosurrounding oral tissues.

The dental treatment compositions include at least one tissue adhesionagent, and may include an optional active agent. Following are examplesof tissue adhesion agents and optional active agents.

1. Tissue Adhesion Agents

The tissue adhesion agent may comprise any known tackifying agent thatis substantially non-adhesive, or less adhesive, when treatmentcomposition is substantially solid but which becomes more adhesive toteeth when the treatment composition is moistened with, e.g., water orsaliva. A presently preferred tissue adhesion agent is polyvinylpyrrolidone (PVP). Examples of other suitable tissue adhesion agentsinclude carboxypolymethylene (e.g., CARBOPOL, sold by Novean, Inc.),polyethylene oxide (e.g., POLYOX, made by Union Carbide), polyacrylicacid polymers or copolymers (e.g., PEMULEN, sold by Novean, Inc.),polyacrylates, polyacrylamides, copolymers of polyacrylic acid andpolyacrylamide, PVP-vinyl acetate copolymers, carboxymethylcellulose,carboxypropylcellulose, polysaccharide gums, proteins, and the like.Characteristics of substantially solid adhesive treatment compositionsin particular, and these and other tissue adhesion agents are disclosedin U.S. patent application Ser. No. 10/446,235, filed May 27, 2003, andtitled TRAY-LIKE DENTAL BLEACHING DEVICES HAVING A BARRIER LAYER AND ASUBSTANTIALLY SOLID BLEACHING COMPOSITION, and U.S. patent applicationSer. No. 10/446,471, filed May 27, 2003, and titled SUBSTANTIALLY SOLIDDENTAL BLEACHING COMPOSITION IN A TRAY-LIKE CONFIGURATION, now U.S. Pat.No. 7,048,543, which are hereby incorporated by reference with respectto their disclosure of substantially solid adhesive compositions andtissue adhesion agents.

The amount of tissue adhesion agent in the dental treatment compositionoften depends on whether the composition is a gel, a putty, or asubstantially solid adhesive composition. According to one embodiment,the one or more tissue adhesion agents are included in an amount in arange of about 10% to about 90% by weight of the treatment composition(exclusive of any bound water or other solvent), more preferably in arange of about 20% to about 80% by weight of the treatment composition,and most preferably in a range of about 40% to about 75% by weight ofthe treatment composition.

2. Active Agents

One or more active agents may be included in the dental treatmentcomposition. Examples of various active agents include dental bleachingagents, desensitizing agents, remineralizing agents, antimicrobialagents, antiplaque agents, anti-tartar agents, or other medicaments.

A common dental bleaching agent that is known to bleach teeth and thathas been found to be safe for oral use is hydrogen peroxide. However,hydrogen peroxide does not itself exist free in nature, but only as anaqueous solution or as a complex. Preferred dental bleaching agentscomprise complexes of hydrogen peroxide because they are more stablethan aqueous hydrogen peroxide, which tends to be unstable when heated,especially when water is removed by evaporation.

Non-limiting examples of complexed hydrogen peroxide include carbamideperoxide and metal perborates. Other bleaching agents that can be usedto bleach teeth include, but are not limited to, metal percarbonates,peroxides, chlorites, and hypochlorites, peroxy acids, and peroxy acidsalts.

If present, the one or more bleaching agents are preferably included inan amount in a range of about 5% to about 80% by weight of the treatmentcomposition, more preferably in a range of about 10% to about 60% byweight of the treatment composition, and most preferably in a range ofabout 20% to about 50% by weight of the treatment composition.

As mentioned, other optional active agents may be included. Examples ofdesensitizing agents include potassium nitrate, other potassium salts,citric acid, citrates, and sodium fluoride. These and otherdesensitizing agents are disclosed in U.S. patent application Ser. No.10/637,237, filed Aug. 8, 2003, and titled SUBSTANTIALLY SOLIDDESENSITIZING COMPOSITIONS AND DEVICES HAVING A TRAY-LIKE CONFIGURATIONAND METHODS OF MANUFACTURING AND USING SUCH COMPOSITIONS AND DEVICES,now issued U.S. Pat. No. 7,059,857, which is hereby incorporated byreference with respect to its disclosure of desensitizing agents.Examples of remineralizing agents include sodium fluoride, stannousfluoride, sodium monofluorophosphate, and other fluoride salts. Examplesof antimicrobial agents include chlorhexidine, triclosan, andtetracycline. Examples of antiplaque and anti-tartar agents includepyrophosphate salts. These and additional medicaments that may beincluded as optional active agents are disclosed in U.S. patentapplication Ser. No. 10/646,484, filed Aug. 22, 2003, and titledCOMPOSITIONS AND DEVICES HAVING A TRAY-LIKE CONFIGURATION FOR DELIVERINGA MEDICAMENT AND METHODS OF MANUFACTURING AND USING SUCH COMPOSITIONSAND DEVICES, now issued U.S. Pat. No. 7,056,118, which is herebyincorporated by reference with respect to its disclosure of activeagents.

3. Other Components

The dental treatment composition may include other components as desiredto yield a final composition having desired properties. Examples ofother components include, but are not limited to, plasticizers andhumectants (e.g., glycerin, sorbitol, and polyethylene glycol), volatilesolvents (e.g., water and alcohols, such as ethanol), bleaching agentstabilizers (e.g., EDTA and alkyl sulfates), bleaching agent activators(e.g., metals and metal compounds) neutralizing agents (e.g., sodiumhydroxide), thickening agents (e.g., fumed silica), flavorants,sweeteners, and the like.

Additional treatment compositions and their components are disclosed inU.S. patent application Ser. No. 10/701,788, filed Nov. 4, 2003, andtitled PRE-SHAPED DENTAL TRAYS AND TREATMENT DEVICES AND METHODS THATUTILIZE SUCH DENTAL TRAYS, now U.S. Pat. No. 6,964,571, and U.S. patentapplication Ser. No. 10/692,117, filed Oct. 22, 2003, and titledBLEACHING COMPOSITIONS AND DEVICES HAVING A SOLID ADHESIVE LAYER ANDBLEACHING GEL ADJACENT THERETO, now U.S. Pat. No. 7,011,523, both ofwhich are hereby incorporated by reference with respect to theirdisclosure of treatment compositions.

C. Characteristics of Tray-Shaped Dental Treatment Devices

The tray-shaped dental treatment devices include at least one of thefollowing anatomical features to enhance the fit of the tray-shapeddental treatment device: (1) the bottom wall includes a plurality ofcuts positioned to help the bottom wall better conform to abrupt changesin the diameters of a person's teeth, particularly where the bicuspidsand canines meet, (2) the bottom wall includes at least one V-shaped orU-shaped indentation configured to be inserted into the depressiontypically found along the top surfaces of a person's molars, and (3) thefront and bottom wall include radii of curvature that account fortypical flaring of a patient's incisors.

Moreover, as shown in FIGS. 1-3 and 5-6, the universal, non-customdental treatment trays according to the invention are substantiallydevoid of structures corresponding to the size and shape of a person'sunique dentition so that the dental trays are designed to fit over aplurality of differently-sized dental arches corresponding to differentpeople. The treatment devices are advantageously flexible and adhesiveso as to readily conform to a wide variety of differently-sized teethand dental arches.

FIG. 1A illustrates a perspective view of an exemplary tray-shapeddental treatment device 100, along with an associated exoskeleton 100 ahaving a handle 103 a. The device 100 of FIG. 1A is sized and configuredfor placement over a person's upper dental arch. In the illustratedembodiment, the tray-shaped dental treatment device includes asubstantially solid adhesive composition 101 which covers all theinterior surfaces of the front wall 102 and the bottom wall 104.

The bottom wall 104 includes a plurality of cuts positioned to help thebottom wall better conform to abrupt changes in the diameters of aperson's teeth, particularly where the bicuspids and canines meet. Thecuts help to compensate for the fact that bicuspids are significantlythicker than canines by allowing for an abrupt discontinuity in thebottom wall 104 of the treatment device 100. Without these cuts thebottom wall 104 would be harder to conform to the canines since theadjacent bicuspids would tend to push the bottom wall 104 away from thecanines, thus potentially dislodging the bottom wall 104 in this region.These and any other cuts within the bottom wall 104 may also helpcompensate for differences between the inner and outer radii of thedental arch generally defined by the inner and outer tooth surfaces. Thecuts in the bottom wall 104 may extend the full width of the bottom wall104.

In the illustrated embodiment, the cuts comprise notches 106. Notches106 allow the bottom wall 104 to more freely spread open or compresswithout catching or overlapping other portions of the bottom wall 104.Notches 106 are positioned to help the bottom wall better conform toabrupt changes in the diameter of a person's teeth, particularly wherethe bicuspids and the canines meet. In the illustrated embodiment, thevertex of each notch 106 initially opens at about 10°. Each notch 106spreads substantially wider before reaching the inside edge of bottomwall 104. In the illustrated embodiment, except for the vertex, thenotches 106 do not include any sharp corners. The corners are preferablyrounded so as to provide a more comfortable fit.

The bottom wall also includes a notch 108 near the front of the bottomwall 104 of the device 100. Optional notch 108 allows the tray-shapeddental treatment device 100 to more easily spread open or compress inthe area of the incisors. This is helpful in allowing the bottom wall104 to more easily conform to differently-sized dental arches. Asillustrated, notch 108 may also have rounded corners.

In the illustrated embodiment, the bottom wall 104 also includes twoV-shaped indentations 110 configured to be inserted into the depressiontypically found along the top surfaces of a person's left and rightmolars. Such a feature provides a tray-shaped dental treatment devicethat better conforms to the person's teeth, resulting in a morecomfortable fit, as further illustrated in FIG. 7A.

FIG. 1B illustrates a perspective view of an exemplary tray-shapeddental treatment device 100′ along with an associated exoskeleton 100 a′having a handle 103 a′. The tray-shaped dental treatment device 100′ issized and configured for placement over a person's lower dental arch. Inthe illustrated embodiment, the tray-shaped dental treatment device 100′includes an adhesive composition 101′. The tray-shaped dental treatmentdevice includes a barrier layer of moisture resistant material having afront side wall 102′ and a bottom wall 104′. Bottom wall 104′ includesnotches 106′ in the bottom wall 104′ positioned so as to help the bottomwall 104′ better conform to abrupt changes in the diameter of a person'steeth, particularly where the bicuspids and canines meet. Bottom wall104′ further includes optional notch 108′, which allows the tray-shapeddental treatment device 100′ to more easily spread open or compress inthe area of the incisors so as to more easily conform todifferently-sized dental arches. Finally, the bottom wall 104′ alsoincludes two V-shaped indentations 110′ configured to be inserted intothe depression typically found along the top surfaces of a person's leftand right molars.

FIG. 2 illustrates a tray-shaped dental treatment device 200 having amoisture-resistant barrier layer 212 having a front side wall 202 and abottom wall 204. The device 200 is held within exoskeleton 200 a. Thetray-shaped dental treatment device 200 also includes a substantiallysolid adhesive composition 201 covering the front side wall 202. Theadhesive composition 201 includes an exterior surface disposed adjacentto an interior surface of the barrier layer 212 and an interior surfacedesigned to directly contact a person's teeth when the tray-shapeddental treatment device 200 is in use.

Bottom wall 204 includes notches 206 in the bottom wall 204 positionedso as to help the bottom wall 204 better conform to abrupt changes inthe diameter of a person's teeth, particularly where the bicuspids andcanines meet. Bottom wall 204 also includes an optional notch 208, whichallows the tray-shaped dental treatment device 200 to more easily spreadopen or compress in the area of the incisors so as to more easilyconform to differently-sized dental arches. The bottom wall 204 alsoincludes two V-shaped indentations 210 configured to be inserted intothe depressions typically found along the top surfaces of a person'sleft and right molars.

FIG. 3 illustrates a tray-shaped dental treatment device 300 having amoisture-resistant barrier layer 312 having a front side wall 302 and abottom wall 304. The device 300 is held within exoskeleton 300 a. Asubstantially solid adhesive composition 301 is disposed adjacent to thefront side wall 302. Tray-shaped dental treatment device 300 alsoincludes a gel treatment composition 314 adjacent to at least one of theadhesive composition 301 or the barrier layer 312.

Bottom wall 304 includes notches 306 in the bottom wall 304 positionedso as to help the bottom wall 304 better conform to abrupt changes inthe diameter of a person's teeth, particularly where the bicuspids andcanines meet. Bottom wall 304 also includes an optional notch 308, whichallows the tray-shaped dental treatment device 300 to more easily spreadopen or compress in the area of the incisors so as to more easilyconform to differently-sized dental arches. The bottom wall 304 alsoincludes two V-shaped indentations 310 configured to be inserted intothe depressions typically found along the top surfaces of a person'sleft and right molars.

FIGS. 4A-4D illustrate cross sections of various other exemplarytray-shaped dental treatment devices. FIG. 4A illustrates a crosssection of a tray-shaped dental treatment device 400 including a frontside wall 402 and a bottom wall 404. A gel treatment composition 414 ispositioned adjacent to both the front side wall 402 and the bottom wall404. FIG. 4B illustrates a cross section of a tray-shaped dentaltreatment device 400 b including a front side wall 402 b and a bottomwall 404 b. A substantially solid adhesive composition 401 b ispositioned adjacent to both the front side wall 402 b and the bottomwall 404 b. FIG. 4C illustrates a cross section of a tray-shaped dentaltreatment device 400 c including a front side wall 402 c and a bottomwall 404 c. A substantially solid adhesive composition 401 c ispositioned adjacent to both the front side wall 402 c and the bottomwall 404 c, while a gel treatment composition 414 c is positionedadjacent to the substantially solid adhesive composition 401 c. FIG. 4Dillustrates a cross section of a tray-shaped dental treatment device 400d including a front side wall 402 d and a bottom wall 404 d. A geltreatment composition 414 d is positioned adjacent to both the frontside wall 402 d and the bottom wall 404 d, while a second gel treatmentcomposition 415 d is positioned adjacent to the front side wall 404 d,near the top. Second gel treatment composition 415 d may be a treatmentcomposition intended to provide no treatment, and to contact the gums.Such a composition preferably contains no dental bleaching agent whichotherwise may irritate the soft tissue surrounding the teeth (e.g.,gingival tissue). Second gel treatment composition 415 d reduces orprevents contact between gel treatment composition 414 d and theperson's soft tissue.

In order to protect a tray-shaped dental treatment device according tothe invention from contaminants during storage and prior to use, thetray-shaped dental treatment device can be packaged within a sealedcontainer or package. As illustrated in FIG. 5, the tray-shaped dentaltreatment device 200, along with an associated exoskeleton 200 a can besealed within a protective package 516 that includes a rigid supportlayer 518 and a peelable cover 520. Although illustrated withtray-shaped dental treatment device 200 and associated exoskeleton 200a, any embodiment of the tray-shaped dental treatment device with orwithout an associated exoskeleton can be sealed within a protectivepackage. When it is desired to use the tray-shaped dental treatmentdevice 200, the peelable cover 520 is removed and the bleaching device200 is removed or separated from the support layer 518. In addition to,or instead of, the protective package 516, the tray-shaped dentaltreatment device 200 may alternatively include a removable protectivelayer (not shown) that is temporarily placed adjacent to the interiorsurface of the adhesive composition 201 and/or a gel or putty treatmentcomposition. When it is desired to use the tray-shaped dental treatmentdevice 200, the removable protective layer is removed so as to exposethe interior surface of the adhesive composition 201 and/or othertreatment composition. In addition, prior to using the tray-shapeddental treatment device 200, a gel or putty treatment composition may beapplied to the inside of the device 200, as shown in FIGS. 3, 4A, 4C, or4D.

In general, the thickness of the adhesive composition layer and thebarrier layer can be adjusted to yield a tray-shaped dental treatmentdevice having a desired strength and flexibility. In order for thebarrier layer to remain flexible so as to conform to a person's teeth,the barrier layer will generally have a thickness ranging from about0.025 mm to about 1.5 mm. When present, the substantially solid adhesivecomposition will generally have a thickness ranging from about 0.1 mm toabout 3 mm. The thickness of the adhesive composition can also beselected depending on the intended duration of each bleaching session.In general, increasing the thickness of the adhesive composition layerwhere the adhesive composition includes a dental bleaching agent willprovide a longer or more sustained release of active dental bleachingagent. By way of example, for short wear times, the adhesive compositionlayer including a dental bleaching agent will preferably have athickness ranging from about 0.1 mm to about 0.5 mm. For intermediatewear times, the adhesive composition layer including a dental bleachingagent will preferably have a thickness ranging from about 0.5 mm toabout 2 mm. For professional use and for overnight bleaching, theadhesive composition layer having a dental bleaching agent willpreferably have a thickness ranging from about 2 mm to about 3 mm.

III. Exemplary Methods of Making Tray-Shaped Dental Treatment Devices

According to one embodiment, the tray-shaped dental treatment deviceincludes a moisture-resistant barrier layer having a front side wall anda bottom wall, a dental treatment composition, and at least one of theanatomical features discussed above to enhance the fit of thetray-shaped dental treatment device.

According to one method of manufacturing one exemplary device, anadhesive composition is made by first forming a flowable compositionthat is later dried to form a substantially solid adhesive composition.This may be performed by heating or otherwise causing one or morevolatile solvents to be driven off by evaporation, thus leaving behind asubstantially solid composition. The drying process may be performedbefore or after the adhesive composition is placed into contact with thebarrier layer.

According to one embodiment, tray-shaped dental treatment devices can bemade by spreading a flowable adhesive composition onto the surface of alarge or continuous polymeric sheet. The polymeric sheet and adhesivecomposition are then placed into a forced air oven, other appropriatedesiccation device, or allowed to dry in ambient conditions. Drying thesheet and adhesive composition drives off a substantial portion of theethanol or other solvent used to form the flowable adhesive composition.Removal of the volatile solvent yields a substantially solid adhesivecomposition. Thereafter, individual tray-shaped dental treatment devicescan be molded, such as by vacuum forming, pressing or stamping from thecoated polymeric sheet and then separated into individual dentaltreatment devices suitable for placement over a person's teeth.

Alternatively, a flowable adhesive composition or a substantially solidadhesive composition can be molded or shaped into a desired tray-likeconfiguration. Thereafter, a barrier layer may be attached or applied toan outer surface of the adhesive composition layer. In this embodiment,the barrier layer may initially comprise a flowable barrier material orprecursor that is later cured or hardened, such as by removing a solventby evaporation, by chemical or light curing, or by cooling athermoplastic melt.

In yet another embodiment of the invention, a barrier layer having afront side wall and a bottom wall can be coated with a flowable adhesivecomposition. The adhesive composition is then heated together with thebarrier layer or otherwise allowed to dry in order to form asubstantially solid adhesive composition. This process can be performedduring commercial manufacture of the tray-shaped dental treatment deviceor by an end user.

Sticky viscous gels, less viscous gels, and/or highly viscous puttiesmay be manufactured separate from the barrier layer. They may be appliedto the barrier layer or an adhesive composition prior to packaging, ifdesired. Alternatively, the tray-shaped dental treatment devices can beprovided with a separate gel or putty which the end user may apply.

The tray-shaped dental treatment devices may be placed within anoptional exoskeleton during the manufacturing process prior topackaging, if desired. Alternatively, the tray-shaped dental treatmentdevices may be provided with a separate exoskeleton, or without anexoskeleton, as desired.

IV. Exemplary Methods of Using Tray-Shaped Dental Treatment Devices

The tray-shaped dental treatment devices according to the invention canbe designed to be worn for any desired time period. Increasing theconcentration of dental bleaching agent in the treatment composition(s)generally reduces the bleaching time required to effect bleaching.Nevertheless, due to the extremely comfortable fit between the inventivetray-shaped dental treatment devices and the person's teeth, it ispossible to wear such devices for extended periods of time in order toensure more uniform bleaching. Especially with respect to tray-shapeddental treatment devices including a substantially solid adhesivecomposition layer, they may be designed to be worn while performingnormal daily activities, such as talking, eating, drinking, smoking,coughing, smiling, frowning, grimacing, or while sleeping. This greatlydecreases their intrusiveness into everyday activities compared toconventional bleaching strips, which do not reliably adhere to teeth, orintrusive bleaching devices such as large, bulky bleaching dentalappliances.

Tray-shaped dental treatment devices according to the invention may beworn over a person's upper dental arch, lower dental arch, or bothsimultaneously. The ability to reliably and comfortably wear tray-shapeddental treatment devices over the upper and lower dental archessimultaneously is another departure from bleaching strips, which are notrecommended for use in bleaching the upper and lower dental arches atthe same time.

FIG. 6A illustrates a person 622 placing a tray-shaped dental treatmentdevice 600 over the person's upper dental arch using an exoskeleton as asupport. FIG. 6B illustrates the person 622 placing a tray-shaped dentaltreatment device 600 over the person's lower dental arch after havingplaced the tray-shaped dental treatment device 600 over the upper dentalarch. It will be appreciated, however, that the tray-shaped dentaltreatment devices can be placed over a person's upper and lower dentalarches in any desired order.

The tray-shaped dental treatment devices 600 and 600′ include aplurality of notches 606 and 606′, respectively, and V-shapedindentations 610 and 610′, respectively, in the bottom wall. FIGS. 6Aand 6B illustrate how the notches 606, 606′ in the bottom wall help thebottom wall better conform to abrupt changes in the diameter of aperson's teeth where the bicuspids and canines meet.

FIG. 7A is a close up cross sectional view illustrating how the V-shapedindentation 610′ in the bottom wall 604′ of tray-shaped dental treatmentdevice 600′ is configured for insertion into the depression in the lowermolar 624′. As seen, molar 624′ includes a depression 626′ into whichV-shaped indentation 610′ is configured to be inserted. This results inbetter conformity between the tray-shaped dental treatment device 600′and the molar 624′, even when downward pressure is applied to the bottomwall 604′.

In the absence of such indentations, the bottom wall 604′ of thetreatment device 600′ may have a tendency to span the molar 624′ like abridge between the generally higher outer edges, thereby leaving a gapbetween the bottom wall 604′ and the surface of the molar 624′ betweenthe outer edges. Permitting such a gap may inhibit or prevent bleachingof the depressed molar surfaces. Moreover, a bottom wall 604′ that isstretched between the outer surfaces so as to leave a gap over the molardepressions may result in inadvertent dislodgment of the treatmentdevice 600′ when the upper and lower molars are brought together. Forexample, if the bottom wall 604′ of a treatment device 600′ is pushedinto the molar depression 626′ by the opposing molars, the front and/orbottom side walls 602′ and 604′, respectively, may be pulled down acrossthe tooth surfaces to compensate for this effective lengthening of thebottom wall 604′ in the vicinity of the patient's molars.

FIG. 7B is a close up cross sectional view illustrating how thecurvature of the front side wall 602 and bottom wall 604 account forflaring of the person's incisors 628. A typical person's incisors arenot vertical. Rather, they typically flare outwards slightly. The frontside wall 602 and bottom wall 604 may have different radii in order tocompensate for the general flaring out of a person's incisors toward theincisal edges. Due to such flaring the diameter of a person's dentalarch at the incisal edges is generally greater than the diameter at thegingival margin. Thus the part of the treatment device 600 correspondingto the incisal edges near a person's incisor 628 may advantageously havea larger radius than the part of the treatment device 600 correspondingto the gingival margin. This helps provide for a better fit of thetreatment device 600 over a person's incisors 628.

To remove the tray-shaped dental treatment device, a user can pry open acorner of the barrier layer using a fingernail or rigid tool and thenpull the remainder off. Any residual adhesive composition or gel orputty treatment composition that remains adhered to the person's teethcan be removed by washing or flushing water over the person's teeth,and/or by brushing. Although the adhesive compositions are very adhesiveto teeth when protected from excessive moisture, they can be formulatedto quickly breakdown and dissolve when flushed with excess water and/orby gentle mechanical action (e.g., brushing).

The tray-shaped dental treatment devices can be worn for as little as afew minutes and as long as several hours. By way of example, notlimitation, a typical bleaching session of fast duration may last fromabout 10 to about 30 minutes. A bleaching session of intermediateduration may last from about 30 minutes to about 2 hours. A bleachingsession of long duration, including professional bleaching or overnightbleaching while a person is sleeping, may last from about 2 hours toabout 12 hours.

Bleaching sessions may be repeated as many times as are needed to obtaina desired degree of whitening. In some cases, a clinical whiteningeffect has been observed after only 1-3 whitening sessions. A typicalbleaching regimen will preferably include 1-20 bleaching sessions, morepreferably 2-15 bleaching sessions, and most preferably 3-10 bleachingsessions.

V. Dental Bleaching Kits

For convenience of use, multiple tray-shaped dental treatment devicesmay be packaged together and sold as a kit. In one embodiment, thenumber treatment devices provided with each kit will equal the number ofsessions that represent a prescribed bleaching regimen.

To efficiently utilize the space within a kit package, multipletray-shaped dental treatment devices can be stacked or interestedtogether. The devices can be sealed collectively or individually asdesired. A protective package 516 is depicted in FIG. 5. The bleachingdevices may optionally contain a removable protective layer on aninterior surface to protect the adhesive composition from contaminationor moisture.

It is within the scope of the invention to provide exoskeletons, barrierlayers, gel or putty treatment compositions, and/or adhesivecompositions that are initially separate and that are brought togetherby the end user. For example, the adhesive composition may be a dryinsert that is placed into a tray-like barrier layer, with or withoutactually adhering the adhesive composition to the barrier layer.Alternatively, a flowable adhesive composition can be placed within atray-like barrier layer and allowed to dry prior to placement of thefinished tray-shaped dental treatment device over the person's teeth.

VI. Examples of the Preferred Embodiments

Following is an example of a tray-shaped dental treatment device thathas been formulated and manufactured according to the invention.Additional examples of treatment compositions and barrier layers thatmay be used are disclosed in U.S. patent application Ser. No.10/446,235, filed May 27, 2003 and titled TRAY-LIKE DENTAL BLEACHINGDEVICES HAVING A BARRIER LAYER AND A SUBSTANTIALLY SOLID BLEACHINGCOMPOSITION, hereby incorporated by reference with respect to examplesof barrier layers and treatment compositions. The exemplary formulationsand manufacturing conditions are given by way of example, and not bylimitation, in order to illustrate tray-shaped dental treatment devicesthat have been found to be useful for bleaching a person's teeth. Unlessotherwise indicated, all percentages are by weight.

EXAMPLE 1

An initially flowable adhesive composition suitable for use inmanufacturing a substantially solid adhesive composition was formed bymixing together the following components: Ethanol 31.95%   Water 10%Polyvinyl Pyrrolidone (M.W. = 1.3 million) 27% Polyvinyl Pyrrolidone(M.W. of about 60,000) 10% Sodium Laurel Sulfate 0.5%  Glycerine 15%Sucralose 25% solution 0.5%  Peach Flavor  4% Potassium Nitrate 0.8% Sodium Fluoride 0.25%  

The resulting adhesive composition was spread over the surface of alarge flat sheet formed of 80% ethyl vinyl acetate and 20%polypropylene. The EVA/PP sheet had a thickness of about 0.15 mm. Theadhesive composition was spread using a skreeding device. The coatedsheet was heated in a forced air oven until the adhesive compositiondried. The coated sheet was removed from the oven and inspected. Theadhesive composition had dried sufficiently so as to form asubstantially solid layer on the surface of the polymer sheet. Theadhesive composition was dry to the touch, but became very sticky whentouched by a wet object. After drying, the adhesive composition film wasreduced to approximately one-third of its original thickness when wet.

The coated sheet was thermoformed into tray-shaped devices with the dryadhesive composition on the inside surface of the devices. Individualtray-shaped devices were cut out using dye cutting tools. A laser couldalternatively be used for cutting. The tray-shaped devices included afront side wall, a bottom wall, a plurality of notches formed in thebottom wall so as to help the bottom wall better conform to abruptchanges in the diameter of a person's teeth, particularly where thebicuspids and canines meet, two V-shaped indentations in the bottom wallconfigured to be inserted into the depression typically found in apersons left and right molars, and a curvature of the front side walland bottom wall that accounts for typical flaring of a person'sincisors.

A bleaching gel treatment composition for use with the tray-shapeddevices was prepared by mixing together the following components: Water22.5% EDTA Disodium  0.1% Carbamide Peroxide 18.5% Sucralose 25%solution 0.75% Glycerine 41.6% Carbopol 974  5.3% Sodium Hydroxide 50%solution 2.25% Polyvinyl Pyrrolidone (M.W. = 1.3 million)   2%Carboxymethyl Cellulose   4% Watermelon Flavor   3%

The tray-shaped devices were placed in a holding device, and a bead ofbleaching gel treatment composition was spread along the front side wallof the bleaching devices. Each tray-shaped device was then transferredto an exoskeleton.

The tray-shaped devices were tested by placing them over a person'steeth. The residual saliva present on the tooth surfaces moistened theexposed surface of the adhesive composition and caused it to becomesticky and very adhesive to teeth almost immediately. The tray-shapeddevices were pressed against the teeth, which caused them to conform tothe natural irregularities of the dental arch and adhere firmly againstthe teeth. The plurality of notches formed in the bottom wall helped thebottom wall better conform to abrupt changes in the diameter of aperson's teeth, particularly where the bicuspids and canines meet. Thetwo V-shaped indentations in the bottom wall were received within thedepression in the left and right molars, and the curvature of the frontside wall and bottom wall resulted in a good fit against the person'soutwardly flared incisors.

The tray-shaped devices were worn for varying time periods ranging fromseveral minutes to several hours without becoming dislodged. In somecases a noticeable bleaching effect was detected after just onebleaching session (e.g., a 2-hour bleaching session). In all cases,noticeable bleaching was detected after 1-3 bleaching sessions.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A pre-shaped, non-customized dental treatment device suitable forplacement over at least a portion of a person's dental arch fortreatment of a person's teeth and/or gums, the dental treatment devicecomprising a moisture-resistant polymeric material having a generallyhorseshoe-shaped configuration so as to substantially correspond to thecurvature of a person's dental arch, the dental treatment device furthercomprising: a front side wall configured to lie adjacent to labial toothsurfaces when the dental treatment device is placed over a person'sdental arch; and a bottom wall, attached to and extending laterally fromsaid front side wall, configured to lie adjacent to occlusal toothsurfaces when the dental treatment device is placed over a person'sdental arch, said bottom wall including at least one V-shaped orU-shaped indentation that is configured to fit into one or moredepressions typically found along occlusal surfaces of a person's molarsin order to improve fit between the dental treatment device and aperson's dental arch, wherein said front side wall and said bottom wallare substantially devoid of structures corresponding to the size andshape of a person's unique dentition so that the dental treatment deviceis designed to comfortably fit over a plurality of differently-sizeddental arches corresponding to different people.
 2. A pre-shaped,non-customized dental treatment device as defined in claim 1, whereinsaid at least one V-shaped or U-shaped indentation extends continuouslyalong a length of said bottom wall so as to span a plurality of aperson's teeth when the dental treatment device is placed over aperson's dental arch.
 3. A pre-shaped, non-customized dental treatmentdevice as defined in claim 1, wherein said front side wall and bottomwall have radii of curvature that account for flaring of a person'sincisors so that the dental treatment device better conforms to theincisors.
 4. A pre-shaped, non-customized dental treatment device asdefined in claim 1, wherein said bottom wall further includes aplurality of notches positioned so that the dental treatment devicebetter conforms to abrupt changes in tooth diameter where a person'sbicuspids and canines meet.
 5. A pre-shaped, non-customized dentaltreatment device as defined in claim 1, wherein said bottom wall furtherincludes a notch positioned so that the dental treatment device moreeasily spreads open or compresses in a region near a person's incisors.6. A pre-shaped, non-customized dental treatment device as defined inclaim 1, wherein the dental treatment device is thin and flexible so asto readily conform to a plurality of differently-sized dental archescorresponding to different people.
 7. A kit for use in providing adesired treatment of a person's teeth and/or gums, comprising: at leastone pre-shaped, non-customized dental treatment device as defined inclaim 1; and at least one treatment composition that is initiallyseparate from said pre-shaped, non-customized dental treatment device.8. A pre-filled, non-customized dental treatment device suitable forplacement over at least a portion of a person's dental arch forproviding a desired treatment of a person's teeth and/or gums, thedental treatment device comprising: a moisture-resistant barrier layercomprised of a polymeric material and having a generallyhorseshoe-shaped configuration so as to substantially correspond to thecurvature of a person's dental arch, said barrier layer furthercomprising: a front side wall configured to lie adjacent to labial toothsurfaces when said barrier layer is placed over a person's dental arch;and a bottom wall, attached to and extending laterally from said frontside wall, configured to lie adjacent to occlusal tooth surfaces whensaid barrier layer is placed over a person's dental arch, said bottomwall including at least one V-shaped or U-shaped indentation that isconfigured to fit into one or more depressions typically found alongocclusal surfaces of a person's molars in order to improve fit betweensaid barrier layer and a person's dental arch, wherein said front sidewall and said bottom wall are substantially devoid of structurescorresponding to the size and shape of a person's unique dentition sothat said barrier layer is designed to comfortably fit over a pluralityof differently-sized dental arches corresponding to different people;and a treatment composition adjacent to at least one of said front sidewall or said bottom wall.
 9. A pre-filled, non-customized dentaltreatment device as defined in claim 8, wherein said at least oneV-shaped or U-shaped indentation extends continuously along a length ofsaid bottom wall so as to span a plurality of teeth when said barrierlayer is placed over a person's dental arch.
 10. A pre-filled,non-customized dental treatment device as defined in claim 8, whereinsaid front side wall and bottom wall have radii of curvature thataccount for flaring of a person's incisors so that said barrier layerbetter conforms to the incisors.
 11. A pre-filled, non-customized dentaltreatment device as defined in claim 8, wherein said bottom wall furtherincludes at least one of: a plurality of notches positioned so that saidbarrier layer better conforms to abrupt changes in tooth diameter wherea person's bicuspids and canines meet; or a notch positioned so thatsaid barrier layer more easily spreads open or compresses in a regionnear a person's incisors.
 12. A pre-filled, non-customized dentaltreatment device as defined in claim 8, wherein said treatmentcomposition comprises at least one of a sticky viscous gel or highlyviscous putty that helps to hold and maintain said barrier layeradjacent to a person's teeth during use.
 13. A pre-filled,non-customized dental treatment device as defined in claim 8, whereinsaid treatment composition is a substantially solid composition thatbecomes more adhesive to teeth when moistened with saliva.
 14. Apre-filled, non-customized dental treatment device as defined in claim8, wherein said treatment composition includes an active agent thatcomprises at least one of a dental bleaching agent, a desensitizingagent, a remineralizing agent, an antimicrobial agent, an antiplaqueagent, an anti-tartar agent, or another medicament.
 15. A pre-filled,non-customized dental treatment device as defined in claim 8, whereinsaid treatment composition includes a tissue adhesion agent thatcomprises at least one of polyvinyl pyrrolidone, carboxypolymethylene,polyethylene oxide, polyacrylic acid, copolymer of polyacrylic acid,polyacrylate, polyacrylamide, copolymer of polyacrylic acid apolysaccharide gum, a protein, PVP-vinyl acetate copolymer,carboxymethylcellulose, carboxypropylcellulose, or polyacrylamide.
 16. Apre-filled, non-customized dental treatment device as defined in claim8, wherein the dental treatment device is contained within a sealedpackage prior to use.
 17. A kit for use in providing a desired treatmentof a person's teeth and/or gums, comprising a plurality of pre-shaped,non-customized dental treatment devices, at least one of which issuitable for placement over at least a portion of a person's upperdental arch and at least one other of which is suitable for placementover at least a portion of a person's lower dental arch, wherein eachdental treatment device comprises: a moisture-resistant barrier layerhaving a generally horseshoe-shaped configuration so as to substantiallycorrespond to the curvature of a person's dental arch, a front side wallof said barrier layer configured to lie adjacent to labial toothsurfaces when said dental treatment device is placed over a person'sdental arch; and a bottom wall of said barrier layer, attached to andextending laterally from said front side wall, configured to lieadjacent to occlusal tooth surfaces when said dental treatment device isplaced over a person's dental arch, said bottom wall including at leastone V-shaped or U-shaped indentation that is configured to be insertedinto one or more depressions typically found along occlusal surfaces ofa person's molars in order to improve fit between said dental treatmentdevice and a person's dental arch, wherein said front side wall and saidbottom wall are substantially devoid of structures corresponding to thesize and shape of a person's unique dentition so that said dentaltreatment device is designed to comfortably fit over a plurality ofdifferently-sized dental arches corresponding to different people.
 18. Akit as defined in claim 17, further comprising a treatment composition.19. A kit as defined in claim 18, wherein said treatment composition ispre-loaded within at least one of said dental treatment devices.
 20. Akit as defined in claim 18, wherein said treatment composition isinitially separate from said pre-shaped, non-customized dental treatmentdevices.